MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problems Signal Artifact/Noise (1036); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system, and a noise and signal loss occurred in which the procedure was cancelled.Noise was seen during ablation on the carto and recording system.Electrocardiogram (ecg) signal disappeared intermittently.The procedure was abandoned.There was no patient consequence.Upon request additional information was received on the event.The signal interference (noise) and signal loss was observed on all ecg channels including body surface and intracardiac.The physician did not have at least one ecg signal available to monitor patient heart rhythm.During ablation all channels lost signals.The patient was under local anesthesia.There was a transseptal puncture performed prior to the cancellation.This event has been assessed as reportable because the lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system, and noise and signal loss occurred in which the procedure was cancelled.Field service engineer arrived on the site and found one damaged pin in the map catheter connector on the backplane card.The backplane card was replaced with another one.After changing the backplane there was no longer noise on the carto on any signal.Full system test has been performed after the backplane replacement.System is running according the specification and is ready for clinical use.The customer performed a procedure and confirmed that all was fine.The defective system was sent to the device manufacturer for investigation.The customer complaint was confirmed.The tvs diode found faulty and caused reported noise issue problem.Also, as was reported, at visual inspection the map connector on the card was found damaged-broken pin.The history of customer complaints associated with carto 3 system was reviewed.There was not any additional complaints that may be related to the reported issue.Device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to investigate 'opto switches and tvs failures'.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4748417
• MDR Text Key: 5825538
• Report Number: 3008203003-2015-00026
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1